Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

• Sponsor: Hospital Avicenne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00957151
• Collaborator: Solvay Pharmaceuticals (Industry)
• Enrollment: 12
• Duration (Months): 16

Study Details

Study Description

Brief Summary

The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Drug: Creon	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis []

Secondary Outcome Measures

1. To determine the efficacy of enzyme therapy []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• subjects with chronic pancreatitis and taking enzyme replacement therapy

Exclusion Criteria:

• patients with hepatic impairment

• patients allergic to dairy proteins

• urinary incontinence affecting the measurement of nitrogen metabolism

• digestive disorder affecting the absorption of nutrients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Avicenne
• Solvay Pharmaceuticals

Investigators

• Principal Investigator: Robert Benamouzig, Pr, Department of Gastroenterology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00957151
• Other Study ID Numbers: 04007
• First Posted: Aug 12, 2009
• Last Update Posted: Aug 12, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: chronic pancreatitis; exocrine pancreatic insufficiency; enzyme therapy; patients with chronic pancreatitis and exocrine pancreatic insufficiency; taking enzyme replacement therapy
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Aug 12, 2009